Identity
- Trade Name
- T2 FDA UDI
- Generic Name
- Flexible intramedullary nail FDA UDI
- Device Name
- Flexible Nail, pre-curved FDA UDI
- Model / Reference
- 0194-1500S FDA UDI
- Description
- Flexible Nail, pre-curved FDA UDI
Identifiers
- Catalog Number
- 0194-1500S FDA UDI
- Primary DI / UDI-DI
- 07613252130604 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Flexible intramedullary nail FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 300.0 Millimeter FDA UDI
Category: Flexible intramedullary nail
T2 by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible intramedullary nail.
- EPIX Distal Screw 65.0mm x 5mm — Epix Orthopaedics Inc. · Class II
- EPIX Distal Screw 75.0mm x 5mm — Epix Orthopaedics Inc. · Class II
- EPIX Assy, Long Nail 10mm x 460mm Right — Epix Orthopaedics Inc. · Class II
- EPIX Assy, Long Nail 10mm x 300mm Right — Epix Orthopaedics Inc. · Class II
- EPIX AntiRotation Device — Epix Orthopaedics Inc. · Class II
- EPIX Lag Screw 100mm x 11mm — Epix Orthopaedics Inc. · Class II
- EPIX Distal Screw 90.0mm x 5mm — Epix Orthopaedics Inc. · Class II
- EPIX Distal Screw 32.5mm x 5mm — Epix Orthopaedics Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 7e7e6a02-f3eb-4d47-ab9e-d96bf127921a 35 fields · synced May 31, 2026